Associate Director of Quality Assurance
This position will manage the development and implementation of quality practices in all operational areas to ensure compliance with the ABL Quality Systems, FDA and EU cGMP regulations. Ensure continuous quality improvement of our processes and systems, making sure that only quality products are delivered to our customers.
The main responsibilities will include but are not limited to:
- Ensure that established procedures are followed and/or are revised accordingly to meet Quality System Regulations and FDA and EU cGMP requirements.
- Ensure that the CAPA system is well defined and implemented. This system includes complaint handling, failure investigation, non-conforming material control etc. Develop, analyze, and improve quality data to support use of the data for continuous quality improvement.
- Identify and develop management methods that support all employees’ involvement in continuous quality improvement, and organize and lead the deployment of these methods.
- Manage resources to support manufacturing, purchasing, supplier audits, process & production control, testing, calibration, documentation control, incoming inspection management reviews etc.
- Ensure accurate documentation and valid clinical evaluation of ABL products, and create and maintain complete dossiers for reviews by regulatory agencies.
- Ensure personal effectiveness and credibility through personal enthusiasm, knowledge of key business operations and needs, participation in key operating teams, and support of key business initiatives.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
- College degree (BS or BA) with 8 to 10 years of experience in a technical field (e.g. .Life Sciences, Microbiology or Chemistry) related to the industry or equivalent. 5 years of direct experience in a management position in a cGMP/ISO environment.
- Must have the ability to influence and motivate others while maintaining a cohesive team environment.
- Effective written and oral communications skills (within all levels of the organization and with external colleagues and collaborators), interpersonal skills, analytical/problem solving skills, cross-functional team leadership skills, goal setting/time management skills are required.
- The position demands the ability to communicate requirements in a manner that avoids hard feelings, and the ability to advocate range and innovation that will engender concurrence rather than resistance.
- Proven multi-tasker able to handle multiple projects well; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments.